Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial to "Study the Efficacy and Therapeutic Safety of Ivermectin: (SAINTBO) (SAINTBO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04836299
Recruitment Status : Not yet recruiting
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
Barcelona Institute for Global Health
Université Catholique de Louvain
Information provided by (Responsible Party):
Jorge Luis Aviles, Universidad Mayor de San Simón

Brief Summary:

Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes a respiratory illness (such as the flu) with symptoms such as cough, fever, and, in more severe cases, respiratory distress, even developing Acute Respiratory Distress Syndrome, evolving in some cases with the death of the patient. Currently, there are no specific treatments for COVID-19. Currently, there are several ongoing clinical trials evaluating possible treatments. Recently, Leon Caly reports here that Ivermectin, an FDA-approved antiparasitic that was shown to have broad-spectrum antiviral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero cells. hours after infection with SARS-CoV-2 capable of a 5000-fold reduction in viral RNA at 48 h. (1) Ivermectin, therefore, warrants further investigation for possible benefits in humans. The reason for this study is to understand the effect of the drug in eradicating the virus.

It is a randomized controlled trial to evaluate the efficacy of Ivermectin in COVID-19. The recruited patient will be assigned to two groups, (1) a group received ivermectin plus care treatment (2) the placebo group plus standard care treatment. The result will be recorded by documenting the RT-PCR reports confirmed at the time of recruitment and at 7 and 14 days within the framework of the study, then they will be adapted to the national care protocol, with 9 scheduled clinical and telemedicine interviews.

It will be a randomized controlled trial to be run in RT-PCR confirmed COVID-19 patients who meet the inclusion criteria (asymptomatic/mild to moderate severity).

They will be divided into groups after randomization. Group A will be administered one (1) a group received ivermectin plus standard of care treatment (2) the placebo group plus standard of care treatment, along with the existing inpatient and outpatient management clinical guidelines of the hospitals participating in the study, these being adapted to the National standard.

The reverse transcriptase-polymerase chain reaction (RT-PCR) will be carried out on days 7 and 14 after the therapeutic intervention and the duration of time at which the RT-PCR becomes negative and/or clinical evolution of the patient will be compared in both study groups. The dose of the drug is not subject to change according to the patient's response or the possible side effect of being administered in a single dose.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin Drug: Placebo Phase 2

Detailed Description:

STUDY DESIGN It is a double-blind, randomized, placebo-controlled superiority trial with two parallel arms. Participants will be randomized to receive a single 600 µg / kg dose of ivermectin or placebo, and the number of patients in the treatment and placebo groups will be in a 2: 1 ratio for the intervention group.

The trial statistician will generate the randomization code using blocks of four individuals to ensure the balance between groups. The assignment will be carried out by the main investigator using opaque envelopes, after obtaining informed consent and verification of compliance with all the inclusion and exclusion criteria. The investigational product will be administered by personnel who are not involved in patient care or monitoring of study participants.

Participants will be followed up at their homes for a period of 28 days. A patient can discontinue her participation in the study at any time and for any reason. The principal investigator and the panel of experts that make up the safety and adverse effects committee may also withdraw a patient from the study if they believe it is in the best interest of the patient.

Serious adverse events (SAEs) related to ivermectin will be followed until they resolve or up to 28 days after the participant's final visit, whichever occurs first. All other SAEs deemed unrelated to ivermectin will be followed up until the participant's final visit or for a specified period at the discretion of the principal investigator.

The study will end when the final randomized patient has completed the study, all planned visits have been completed, and inconsistencies in the data have been resolved.

OBJECTIVES Primary objective

• To explore the efficacy and therapeutic safety of Ivermectin in patients with non-severe and low-risk COVID-19 in the first 72 hours after the onset of symptoms, through the negativization of the polymerase chain in real time. RT-PCR (nasopharyngeal swab) and clinical improvement on day 7 and 28 after treatment, to explore its possible use in the fight against the pandemic.

Secondary objectives

  1. To evaluate the efficacy of ivermectin in reducing the SARS-CoV-2 viral load in the nasopharyngeal swab on day 7 after treatment.
  2. To evaluate the efficacy of ivermectin in improving the progression of symptoms in treated patients.
  3. Assess the proportion of seroconversions in patients treated on day 21.
  4. Evaluate the safety of ivermectin at the proposed dose.
  5. Determine the magnitude of the immune response against SARS-CoV-2
  6. Evaluate the early kinetics of immunity against SARS-CoV-2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, double-blind, Placebo-controlled parallel clinical trial to "Study the efficacy and therapeutic safety of Ivermectin associated with standard of care treatment versus placebo with standard of care treatment in the early phase of coronavirus infection (COVID19).

A PHASE II pilot study.

Masking: Double (Participant, Care Provider)
Masking Description: The participants, care providers and also investigator will be blinded for this study design.
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Therapeutic Safety of Ivermectin Versus Placebo Associated With Standard of Care Treatment in the Early Phase of Coronavirus Infection (COVID19).
Estimated Study Start Date : May 8, 2021
Estimated Primary Completion Date : July 8, 2021
Estimated Study Completion Date : December 5, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin
Participants will receive a single 600 µg / kg dose of ivermectin.
Drug: Ivermectin
Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.
Other Name: A

Placebo Comparator: Placebo Comparator
Participants will receive a single dose of placebo.
Drug: Placebo
Participants will be randomly assigned to receive a single of placebo.
Other Name: B




Primary Outcome Measures :
  1. Evolution of viral load [ Time Frame: 3 days ]
    A comparison will be made between the initial viral load before the dose of ivermectin with respect to the viral load on the third day after the administration of the drug. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, with the endpoint of measurement relative to the difference in viral loads.

  2. Clinical remission [ Time Frame: 28 days ]
    Clinical remission, defined as a remission of all the patient's symptoms based on the clinical management protocol. The primary outcome of interest will be the correlation between the use of a treatment regimen containing Ivermectin plus the standard of care, initiated early after the confirmed diagnosis of COVID-19 with the endpoint of measurement relative to the difference in clinical evolution.


Secondary Outcome Measures :
  1. Clinical signs of toxicity [ Time Frame: 28 days ]
    The secondary outcome of interest will be the correlation between these treatment regimens and the appearance of clinical signs of toxicity or adverse effects (defined as the first clinical or laboratory finding of a neurological, hepatic, renal, hematological, or pancreatic alteration, or verification of alterations in pupillometry during the outpatient clinical course or hospitalization.


Other Outcome Measures:
  1. Need for supplemental oxygen [ Time Frame: 28 days ]
    The need for supplemental oxygen implementation will be evaluated

  2. Hospital stay [ Time Frame: 3 months ]
    The need for hospital care and the stay both in general wards and in intensive care (ICU) will be evaluated.

  3. Need for mechanical ventilation [ Time Frame: 21 days ]
    The need to implement the intervention through mechanical ventilation will be evaluated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed case of COVID-19 in national reference hospitals - COVID sentinel hospitals.
  • Male and female patients 18 to 75 years (inclusive) of age.
  • Supply of signed and dated informed consent form
  • Declared availability to comply with all study procedures and availability for the duration of the study.
  • In good general health with mild or moderate symptoms during the first week of disease evolution (onset of symptoms maximum 7 days before recruitment).
  • Ability to take oral medications and be willing to adhere to the medication consumption regimen prescribed in the study.
  • The patient must, in the opinion of the principal investigator, be able to comply with all the requirements of the clinical trial (including home monitoring during isolation).
  • The patient is able and willing to comply with the requirements of this test protocol. Voluntarily signed informed consent obtained prior to any proceeding related to the trial.

Exclusion Criteria:

  1. Known history of ivermectin allergy
  2. Hypersensitivity to any component of ivermectin or the excipients of the brand to be used.
  3. COVID-19 pneumonia

    • Diagnosed by the treating physician
    • Identified on a chest x-ray
  4. Fever or cough present for more than 48 hours.
  5. immunoglobulin G (IgG) positive against SARS-CoV-2 by a rapid diagnostic test

8. Recent travel history to loa endemic countries (Angola, Cameroon, Central African Republic, Chad, the Democratic Republic of the Congo, Ethiopia, Equatorial Guinea, Gabon, Republic of the Congo, Nigeria, and Sudan) 9. Current use of quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir, or cobicistat. Use of critical drugs such as warfarin.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836299


Contacts
Layout table for location contacts
Contact: Jorge L Aviles, MPH +59170745106 georgeavi@hotmail.com

Locations
Layout table for location information
Bolivia
Universidad Mayor de San Simón
Cochabamba, Bolivia
Sponsors and Collaborators
Universidad Mayor de San Simón
Barcelona Institute for Global Health
Université Catholique de Louvain
Investigators
Layout table for investigator information
Study Director: Carlos L Erostegui, MPH Universidad Mayor de San Simón
Additional Information:
Publications:
The FDA-approved Drug Ivermectin inhibits the replication of SARS-CoV-2 in vitro https://doi.org/10.1016/j.antiviral.2020.104787. https://covid19-evidence.paho.org/handle/20.500.12663/988?locale-attribute=es

Layout table for additonal information
Responsible Party: Jorge Luis Aviles, MD. MPH. PhDc., Universidad Mayor de San Simón
ClinicalTrials.gov Identifier: NCT04836299    
Other Study ID Numbers: RCT01
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is planned to grant the respective information stored in a repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: until August 2021
Access Criteria: unrestricted access

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jorge Luis Aviles, Universidad Mayor de San Simón:
Efficacy
Safety
Ivermectin
Additional relevant MeSH terms:
Layout table for MeSH terms
Ivermectin
Antiparasitic Agents
Anti-Infective Agents